REVIEW OF EPA'S REGIONAL PESTICIDES PROGRAM
                 May 10,  1976
           Program Evaluation Division
                           •
         Office of Planning and Evaluation

        Office of Planning and Management

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       UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                        WASHINGTON. D.C. 20460
                           JUL8   1978
                                                           OFFICE OF
                                                     PLANNING AND MANAGEMENT
SUBJECT:   Pesticides Regional Operations Review  •

FROM:      Alvin L. Aim, Assistant Administrator
              for Planning and Management (PM^JOS)

            Andrew W. Breidenbach, Assfsfant Administrator*
             •for Water and Hazardous Materials (WH-556)

            Stanley Legro, Assistant Admin,},
              for Enforcement (EN-329,

TO:      '   Russell E.  Train, Administrator
     On September 15, 1975, we initiated a review of Regional operations
in the pesticide program that was conducted by the Office of Pesticide
Programs, the Pesticide Enforcement Division, and the Program Evaluation"
Division.  The final report of the Review Team is attached. In conducting
this review, the team interviewed pesticide program managers at Head-
quarters and visited all ten Regional Pesticide Branches, as well as six State
pesticide offices. The report has been circulated among Headquarters
and Regional Offices and the recommendations made in this memorandum
take their comments into account.

     The Review Team was favorably impressed by the Regional pesticide
programs.  Despite meager resources, the Branches do a  good job of
fulfilling their important responsibilities.  Other major findings of the
Review Team  are:

     • Regional Pesticide Branches generally have strong and effective
        enforcement programs, particularly for pesticide supply control.
        Much  of the past success of enforcement efforts may be attributed
        to program decentralization.   Currently there is a shift in emphasis
        to use control.  The FY 77 Regional Guidance and the Inspector's
        Manual provide the basic instructions  for use observation.  The over-
        all use control strategy will have to evolve from the experience of
        the Regions and continued follow-up by the Pesticides Enforcement
        Division.

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                             -2-
     •  Controlling the supply and use of pesticides is'a massive task
        which could legitimately consume far greater resources than
        will ever be available.  But most Regions have not effectively
        coordinated their efforts with those of the States to get the most
        out of resources that are available.
                                        •
     •  The role of the Pesticid-e Branches in program operations -and
        technical assistance can and should be greater. Now that the
        uncertainty with  respect to Section 4 of FIFRA has been resolved
        by Congressional amendment the Branches can move ahead in
        helping States to establish operational certification programs.
        Better OPP Headquarters  support in providing the Regions with
        consistent policy information and guidance as well as increased
        authority in all program areas is essential.  However, a concen-
        trated attempt by each Region to understand,  complement and
        utilize that guidance is also required, even with limited Regional
        staff.

     These general conclusions, along with the other more specific ob-
servations detailed in the report, led the Review Teams to four major
recommendations:

     1)  A strategy for decentralizing pesticide responsibilities should
        be developed,  particularly in abatement and control.

     2)  The-Agency should manage the manpower resources devoted to
        pesticides in  such a way as to make the  implementation of a
        decentralization  strategy possible. The Headquarters/Regional
        personnel balance should be  evaluated on a case specific basis
        whenever manpower reductions become-necessary.  Every effort
        should be made to minimize  personnel cutbacks in the Regions.

     3)  Pesticide Branch Chiefs can make  the most effective use of
        their resources by encouraging more interaction between enforce-
        ment and abatement and control activities.

     4)  Pesticide Branches must make a greater effort to coordinate
        with the States by involving States in program planning and
        implementation,  reaching  agreements on inspections and sur-
        veillance, and fostering State assumption of some regulatory
        responsibilities.

     To ensure these  broad-based recommendations are implemented and
to improve the overall efficiency and effectiveness'of program planning,
operations, and management, we submit,  for your approval, the following
list of actions suggested  by the Review Team:

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                              -3-
The Review Team recommends that the Administrator:

     -  Delegate responsibility for approving State certification plans
        to Regional Administrators.

     -  Delegate responsibility for approving State plans for special
        local use registrations to Regional Administrators.

     -  Delegate authority to the Regional Administrator to veto, when
        necessary, an experimental use permit granted by a State pur-
        suant to the conditions set forth in Section 5(f).

The Review Team recommends that the Dsputy Assistant Administrator
for Pesticide  Programs:

     -  Initiate a pilot program in late FY 77 or early FY 78 to assess
        the feasibility and cost-effectiveness of decentralizing certain
        registration functions.

     -  Ensure promulgation of the following items by the identified deadline.

        -  disposal regulations               August 15, 1976
        -  §5(f) regulations                  September 3,  1976
        -  §24(c) regulations                 November 1,  1976
        -  packaging regulations       •      January 15, 1977 .

     -  Instruct Headquarters pesticide personnel not to deal with a
        State  on substantive issues without prior Regional consultation,
        except under emergency conditions.
                       ^
     -  Complete by October  1,  1976 a review of the Pesticide Episode
        Reporting System to determine its value and its organizational
        relationship to the Hazard Evaluation System.

     -  Finish the Hazard Evaluation planning effort by November 1976.

  The Review  Team recommends that the Director of the Registration
  Division (OPP):

     -  Improve the system for tracking the progress of ID'S through
        the registration review process. This will include identifying
        specific responsibility for contacting the Regions by phone if
        a review takes longer than 15  days.

     -  Develop procedures to ensure that the individual who reviews a
        product suspected of violating FIFRA, is the same one who par-
        ticipates in subsequent enforcement  proc-e'dures. However, Regions
        should be the primary source.of expert witnesses for enforcement
        actions.

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                            • -4-
     -  Ensure that during the ninety day period when. EPA can reject
        a State registration made under §24(c) authority, information re-
       flating to the local problem and the economic impact of denial
       ks obtained from the responsible Region. •

     -  Grant a- §18 emergency exemption only after obtaining Regional
        input.

     -  Renew an emergency exemption only after a review to determine
        if the product should be registered for the use in question.

The Review Team recommends that the Director of the Technical Services
Division (OPP):

     -  Prepare a Pesticide Analysis Retrieval and Control System User's
        Manual ancTconsider options for distributing~the PAR~CS micro-
        fiche to non-EPA groups.

     -  Take the lead in establishing formal procedures for dealing with
        conflicting efficacy test results and resolving Regional/CBIB
        disagreements.

     -  Develop,  with the advice of the Pesticides Enforcement Division,
        guidance on manpower  requirements for the Product Analysis
        Laboratories, as well as analysis quotas and priorities.

     -  Ensure the participation of the Pesticides Enforcement Division'
        and all of the Pesticide Branches in the design and implementation
        of the Hazard Evaluation System.

     -  Provide guidance to ensure close Headquarters/Regional/State
        coordination of ambient monitoring efforts.

     -  Establish, in cooperation with FED and the Denver NEIC, a policy
        for the analysis of residue samples.

The Review Team recommends that  the Director of the Operations Division
(OPP):

     -  Design a system, using the Regional Coordinators,  to ensure
        that inquiries from the Regions are promptly answered and that
        all responses are definitive  and consistent.

     -  See that all available suspect chemical,  suspect product or suspect
       'use information is distributed to the Pesticide Branches.

     -  Provide comments on any draft State plan'within 15 working days.

     -  Develop criteria for determining when applicator training funds
        are to be transferred to a State Cooperative Extension  Service.

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                              -5-
The Review Team recommends that the Director of the Pesticides
Enforcement Division (OE):

     -  See that the Regions have all the data necessary to develop
        comprehensive inspection strategies, including toxicity classi-
        fication and information on production,  violations and previous
        sampling.

     -  Streamline the Pesticide Enforcement Management System so
        that it will be oFgreater practical use to the Pesticide Branches
        and the Office of Pesticide Programs.   Unused information should
        be dropped and programs for accessing and evaluating the remaining
        data should be prepared.

     -  Prepare a PEMS user's manual that goes beyond technical des-
        criptions of the system and discusses the services and information
        PEMS ean provide.

     -  Lead a session long enough to adequately discuss and cover the
        Regional use enforcement strategy at the.next scheduled Branch
        Chiefs' meeting.

     -  Waive concurrence on §13 Stpp Sale notices and non-use related
     .   §9(c) and §14 (a)(2) warnings'in the case of Regions that have
        demonstrated'the competence to handle these actions on their
        own.  Concurrence will be relaxed on use related warnings once
        the Regions have had experience dealing with use violations.

     -  Standardize the format for submissions to the Pesticides  Misuse
        Review Committee and expedite the PMRC review.  The PltflRC .
        Manual will be revised to reflect policy and organizational changes.

     -  Develop and transmit to the Pesticide Branches clear guidance
        on the National Environmental Investigation Center's pesticides
        responsibilities and capabilities.

The Review Team recommends that the Regional Pesticide Branch Chiefs;

     -  Re-examine resources commited to establishment inspections
        making shifts to higher priority activities where appropriate.

     -  Send to the States copies of the Regional Guidance, work plans
        and other strategic documents as appropriate.

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                              -6-
     -  Emphasize use observation and acquainting applicators with use
        requirements, particularly those contained in the Pesticides
        Enforcement Policy Statements.

     -  Make special efforts to acquaint manufacturers and formulators
        with registration guidelines, and'to provide -them with information
        bearing on registration matters.

The Review Team recommends that the Director of the  Standards and
Regulations Division (OPM):

     -  Provide assistance necessary  to get the following regulations
        promulgated by the identified deadline.

        -  disposal regulations             August 15, 1976
        -  §5(f) regulations                September 3, 1976
        -  §24(c) regulations               November 1,  1976
        -  packaging regulations           January 15,  1977
                                   Approve \J<*fC^ pŁgx^*^g&^ IcfIng

                                Disapprove!^

                                      Other
                                       Date  LA  ,2,0
                                           V

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REVIEW OF EPA'S REGIONAL PESTICIDES PROGRAM
                 May 10,  1976
           Program Evaluation Division
                           •
         Office of Planning and Evaluation

        Office of Planning and Management

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                        I.  INTRODUCTION
A.  Background

     Since December 1974, the Program Evaluation Division has been con-

ducting a long-term review of the Agency's pesticide program under the

Federal Insecticide, Fungicide and Rodenticide Act, as amended (FIFRA).

The review has already produced a number of short, operationally relevant

issue papers on various aspects of the program. This report  was initiated

by a joint  memorandum from Messers.  Aim, Breidenbach and Legro.
                    i                                              »
It was undertaken in response to a request to review the current role of

the Regional Offices in implementing the pesticide program and to formulate

appropriate  recommendations.. The study was conducted by a Review

Team composed of representatives from the Office Of Pesticide Programs

(OWHM),  the Pesticide Enforcement Division (OE),  and the Program

Evaluation Division (OPM).  Pesticide program managers at Headquarters

and all ten Regions were interviewed. In addition, the Team  visited six

State pesticide offices.  On Regional and State visits, the Team was

accompanied by a Pesticide Branch Chief from a Region other than the one

being visited.

     The next section of this  report summarizes our general  conclusions.

Chapters II-IV detail our findings and recommendations on the Regional role

in the major areas of program activity.  The final Chapter V  provides some

perspectives on the allocation of Regional pesticide  manpower resources.

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                                 -2-



B.  General Conclusions



    The pesticide strategy document identifies three major areas of program



activity: supply control, use control, and hazard evaluation. . The main



elements of supply control are registration, suspension and cancellation of



registrations, tolerance setting,  and producer and market place surveillance.



Use control involves training and certifying applicators,  ensuring appropriate



labeling, regulating storage and disposal, investigating accidents, and enforcing



against improper pesticide use.   Hazard evaluation is  the accumulation and



assessment of data regarding the impact of pesticides  on man and the environ-



ment.



     In general, the Review Team was favorably impressed by the Regional



pesticide programs.  Despite meager resources, the Branches do a good job



of fulfilling their major responsibilities.  This is particularly true of supply



enforcement activities, which have historically been the focus of the Regions.



Not only are inspection and surveillance commitments met, but the Branch



Chiefs point to an overall decrease in the number of unregistered establishments



and pesticides.  Generally, the Branches achieve good coverage of manufacturers



and products,  although some improvements are necessary in the development



of the inspectors'  work plans.  In most Regions the necessary enforcement



actions are taken in a  timely fashion.  Branch Chiefs report very few repeat



episodes dealing with the  same firm and the same problem.



     Much of the success of the enforcement effort results from the decentralized



nature of the program. The Pesticides Enforcement Division provides general



guidance, but the Branches do most of their own planning and decision making.



Some of the success also  stems from the fact that the  supply enforcement effort



is a well established program with precisely defined objectives and experienced



personnel.

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                                -3-

     Further along these lines,  it is our conclusion that the Regional organi-

zational structure apparently has little to do with program success in general.

The programs in Regions II and IX, where enforcement and technical assistance

are separated,  do not work perceptibly better or worse than the other eight

Regions where all pesticide activities are in one Branch.  Much more important

than structure is function.   The Regions  that are most effective have consider-

able overlap between enforcement and program  activities. Personnel perform

a variety of tasks which may extend into  either sphere of responsibility.

Inspectors are not just enforcement agents but educators and State li'ason

assistants as well.  Technical assistance staffs  provide aid and support in

ensuring that pesticide manufacturers and users understand and do not  break

the law.  The Review Team encourages all Regions to follow this coordinated

approach in carrying out their responsibilities.

    The 1972 amendments  to FIFRA,  however,  added new responsibilities to the

control of pesticides, largely elements of use control and the hazard evaluation

function.  Regional activities in these areas are less well established.  -This is,

at least in part, a function of the fact that Headquarters has not fully articulated

the Agency's policy in these areas. As more emphasis is given to these newer

responsibilities, the Regional role will change rapidly.  The potential policy

and methodological problems will have to be solved through a joint Headquarters/
                         •     •
Regional effort.

     An example of the problems with the 1972 Amendments is that the  technical

assistance goals of the Pesticide Branches are less specific than are the  supply

control goals.  The primary Regional objective  has been to foster the development

of State enabling legislation and operational programs that will fulfill the  require-

ments of amended FIFRA.   Under the best of circumstances, persuading  States

to set up new regulatory programs is not easy.  Unfortunately, the Regional

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                                    -4-



Branches have been hampered by inadequate and shifting guidance from Head-


quarters offices.  This poor guidance results partly from Congressional un-


certainties and partly from a failure of all Headquarters units involved to meet


deadlines and to coordinate decision making activities. Other technical assistance


activities have had additional problems.  The Branches generally lack both the


information and authority to make decisive  policy judgments in technical assis-


tance areas.  This minimizes their effectiveness and consequently impairs


their relations with States, pesticides manufacturers, and pesticides users,


all of whom expect the Branch to represent the Agency. Furthermore, most


Regions do not have sufficient scientific expertise to respond to technical


issues or environmental problems  that arise with respect to pesticides, although


in some cases (e.g., participation in the National Monitoring Program) Regions


themselves have failed to respond to opportunities to  participate.  Nevertheless,


most technical assistance  sections of the Pesticide Branches are not well


equipped to provide required technical assistance, let alone be active in data
           .                                     «

gathering, pesticide education or related activities.


     The Review Team found that the technical assistance potential of the


Regional Offices is not being fully utilized.   Given more responsibility  and


greater resources, they could better handle duties still tightly  controlled by


Headquarters, for example, supplying basic registration information, doing


some types of product registration, approving State certification plans, and


proviVLins-adequate support for accident and use investigation. Admittedly,


at this stage of the implementation of amended FIFRA,  technical assistance


activities are much more dependent on Headquarters  policy guidance than are


-enforcement activities.  Consequently, immediate decentralization of the major


activities of the Office of Pesticide Programs may not be  possible.  Nevertheless,

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                                 -5-

certain additional responsibilities should be delegated to the Regions at this
•time, and much more should be Regionalized in the future.  The Review Team
is hesitant to recommend too much registration decentralization until after
reregistration has been completed.  On the other hand, delegating to the Regions
the responsibility for making the final decision on State plans for Section 4,
5f, and 24c should be a very high priority, since the Regions have done much
of the work and are the main lines of communication to the States. There is
no question that once October 1977 is passed,  Regional capabilities should be
strongly augmented, especially in the  area of scientific expertise for regis-
tration and enforcement ID review.  In the meantime,  the Review Team urges
that no reductions be made in total Regional pesticide  manpower. While not
all Branches are equally constrained,  some seem to be understaffed in relation
to their responsibilities.  If any action is taken with regard to resources,  it
should probably be a reallocation among Regions. Chapter V offers some
perspectives in this regard.
     One area of weakness was clearly apparent during the Review Team's
visits: the Regions must make  a much greater effort to involve States  in pro-
gram planning and implementation. To date Regions have met with mixed
success in obtaining cooperative agreements with States for enforcement and
other activities.  The problem is that often the Regions ask the States to co-
operate without first indicating their willingness to cooperate in  return.
For example, some Regions do not usually discuss their workplans with the
States,  and few routine attempts are made to coordinate enforcement inspections
and surveillance.

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                                 -6-
     With the expansion of activities under FIFRA, fostering State cooperation



is imperative.  EPA pesticide resources will never be great enough to do



everything desirable; they must be programmed to avoid unnecessary duplication



of State efforts.

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                                 -7-



                         II.  SUPPLY CONTROL



     The Agency's objective with respect to pesticide supply is to ensure that



available products are safe  and  effective when used as directed. The activities



dealing with supply control  include registration of pesticide products, registration



of producer establishments, surveillance of producers and retailers, control



of imports, experimental use  permits, special local need registrations, and



emergency exemptions.  This chapter briefly describes the activities now per-



formed by  the Regional Offices, discusses the relationships of the  Regional



Offices and Headquarters and makes several recommendations.



     A. Product Registration.



     Section 3 (a) of the FIFRA,  as amended,  requires that all pesticides used



in the United States be registered with EPA.  The conditions of registration



are contained in Section 3(c)(5) and explained in detail in EPA's Section 3 regu-



lations.  Recent extensions  of the Act have  given the Registration Division



(OPP) until October 1977 to  complete the registration or reregistration of an



estimated 30, 000 products.



     Regional Role. As presently organized,  the Regional Offices have been del-



egated only minimal registration responsibilities.  Agency management has



reasoned that: (1) existing data cannot be duplicated and stored in each Regional



Office at a reasonable cost; (2) the minimum necessary level of expertise can



not be developed in each Region; and, (3) a  centralized operation is needed to



ensure a consistent national registration policy.



     Originally  the study team recommended that OPP immediately  transfer



an additional position to each  Regional Office to serve as the reregistration



specialist.  A subsequent evaluation of the reregistration process has revealed



that even though this recommendation is desirable, it is not now feasible.



A process  for registering /reregistering the  30,000 pesticides has now been

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                                  -8-


established in'which the Product Manager is the focal point. A notice was

published in the February 17, 1976 Federal Register directing applicants to

address all inquiries to the Product Manager responsible for the product's

active ingredient.  The notice published Product Manager telephone numbers

and active ingredient assignments.  If there  is to be a chance of meeting the

October 1977 deadline, OPP must stick with  the current process. Until the

reregistration workload is completed the Regional Office  should refer manu-

facturers and applicants to the appropriate Product Manager.

     After October 1977 the possibilities for decentralization (particularly the

approval of distributor labels and minor label changes) should be further inves-

tigated.  A demonstration project,  as was at one time proposed for FY 77,

would be the best way  to determine what changes would be efficient and effective.
                                     •
In the meantime, OPP should know that Regions are spending considerable time

(up to 30 hours per week in some places) answering basic questions concerning

registration.  Adequate provision should be made to enable Regions to handle

routine inquiries and dealings with  local people and companies.

      Recommendation 1; OPP  should complete a pilot program  in FY 1978 to
as'sess the feasibility and cost-effectiveness of decentralizing certain registration
functions.

      Headquarters Support.  The Pesticide Branches in the Regional Offices

depend on Headquarters for policy  guidance and assistance to answer questions

directed to the Regional Office and  to perform assigned duties properly. Regional

personnel interviewed by the Review Team reported that the support  received

from the Office of Pesticide Programs (OPP) has been inadequate. Inconsistent

policy guidance, processing delays and lack of response were mentioned often

as problems which adversely affect the Regional Offices and the Pesticide Branch

staff. At the same time the service which the Agency should be providing to-the

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                                 -9-

public has suffered.  Delays due to Congressional uncertainty, changed rules

and internal inconsistencies have adversely influence'd the effectiveness of the

Regions and given EPA an unnecessarily bad public image.  ,.

     Recommendation 2;  Regulations and policies should be promulgated on
schedule. The Office of Pesticides Programs should complete the following
items by the designated deadline.

     - microfilm of product labels         August 1,  1976
     - disposal regulations                August 15, 1976
     - §5(f) regulations                   September 3, 1976
     - §24(c) regulations                  November 1,  1976
     - packaging regulations              January- 15,  1977

     The Standards and Regulations Division of the Office of Planning and Manage-
ment should provide assistance as necessary and help to ensure that these dead-
lines are met.

     A common complaint in the Regions is that getting answers from OPP is

difficult, if not impossible.  (PED, on the other hand, always is quick to help.)

Frequently OPP "authorities" are not able to provide answers,  and in many

cases the person contacted is not responsive at all.  One Region finds that

obtaining information from the Registration Division is so hard  that the first

thing they now do is  call their Headquarters Pesticides Enforcement Division

coordinator for assistance.   Notwithstanding the designation of the Product

Manager as the contact for reregistration questions,  Regions still must be

able to get responsive answers to other kinds of questions that arise.

     Recommendation 3; OPP must design a process for  ensuring that Regional
inquiries are promptly answered and that all responses are definitive and con-
sistent. The Operations Division Regional coordinators,  like their counterparts
in the Pesticides Enforcement  Division, should have the authority, capability,
and responsibility to help Regional personnel get answers from  all OPP
personnel to their questions, and  stand behind the decisions given.

     Currently, the  Regions lack  basic data—chemical formulation,  toxicity,

target pests, usage  sites--about  most pesticides they are regulating. This is

a major reason why  they remain  so dependent on OPP (particulary the Regis-

tration Division) for information.  The Pesticides Analysis and Retrieval

Control System (PARCS) has been designed to provide to  the Regions not  only

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                                   -10-
copies of all product labels, but also cross-referenced materials about

pesticide composition and intended use. It is imperative  that the Regions

receive the basic system components as soon as possible.

     Recommendation 4;  The Technical Services Division should complete a
plan for making PARCS microfiche available not only to the Regional Offices,
but to other groups involved in pesticides use as well (e.g.,  State agricultural
officials, County extension agents). The plan should include considerations
for providing the necessary microfiche  readers and recommend financial •
arrangements for microfiche distribution. A user manual should be ready
to go with each shipment of the  microfiche.

     B.   Surveillance of Producers and Retailers.

     Section 7(a) of FIFRA, as  amended requires registration with  EPA of all

establishments producing pesticides for use in the United'States. Section 7(c)

requires producers to inform the Agency annually of the  types and amounts of

pesticides produced,  sold and distributed. Section 9 authorizes EPA employees

to enter producing establishments to inspect and obtain samples of pesticides

released for shipment and to examine the collected  samples to determine

whether they comply  with the provision of the Act.

     Inspection Strategy - Marketplace inspections  and producer surveillance

appear to operate .efficiently and have been effective in securing industry

compliance with the new registration regulations. Most Regions have completed

the initial effort to inspect every establishment in the last two years.  Now that

this first step is  past, the^ industry compliance effort must be more carefully

directed by a  system of priorities based on four factors:

     1)  Hazard of the product.
     2)  Volume produced.
     3)  Violative history of the  firm and/or  product.
     4)  Sampling history of the  product.

     Information about these factors is only  partially available to the Regions  in a

usable form.  For factor #1, hazard generally relates to toxicity, persistence,

and availability of antidotes. Specific information of this  sort is on  each product

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                                    -11-

 label, but complicated and careful manual searching would be required to develop

 specific hazard information. In any case, most Regions don't have a complete set

 of the labels.  OPP has begun distribution of the PARCS microfiche list which in-

 dicates relative toxicity on a 1-5 scale.

    For factor #2, annual production reports (§7c) are being coded into the Establish-

 ment Registration Support System (ERSS) which is already available to and utilized

 by Regional enforcement programs.

    For factor #3, PEMS Violative History Reports are available, but they are

 frequently not kept up to date by the Regions.  In fact  most Regions use their own

 files as the primary source for company violative histories.

 -   For factor #4, the Pesticides Enforcement Management  System (PEMS)

 "Quarterly Sampling Report" lists all the dates when a particular product was

 sampled.  This report is widely used to assure regular sampling of individual

 products.

    These four basic pieces of information are provided to the Regions  through

 four different printouts, with the result that  the Regions must make 120,000

 separate manual references  (30, 000 products x 4 criteria) to assemble the basic

 data for development of a Regional sampling strategy.  Better coordination of the

 references for the design of sampling strategy is needed if the sampling program

 is to be effective.

    Recommendation 5; The Pesticides  Enforcement Division, with increased
*n?hTnir°mothe ??C! °Ł Pei?ticides Programs,  must assure that the Regions have
SiSf ntCefSa0ry da a todevelop comprehensive inspection strategies.  Specifically,
the Quarterly  Sampling Report should be improved by the addition of three

5SŁefA H^'fS flriH-  the  V5 tOXi°ity C°de fr°m PARCS' second- some simP1e
code (A-H?) for relative volume of production from the §7C reports*, and third
some reference to products on the Suspect Products List.  Data from the
Violative History Report should not be factored automatically into the Quarterly
Sampling Report until it is up-to-date and accurate.  Meanwhile, the Regions
should continue to  rely on their files for this information.


*yoiume of production  is confidential information.  Care will have to be taken
 to ensure, that the Quarterly  Sampling  Report is used  for internal planning
 purposes only.                                                       °

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                                    -12-


    Data support - As noted above,  PEMS is intended to support the supply

enforcement effort, including the development of the inspection strategy.  However,

it has been the subject of controversy for some time.  In theory PEMS provides a

nationwide record of all inspection visits made,  all pesticides samples collected,

violations, and the resulting enforcement actions taken.  In practice, effective

implementation of PEMS has been hampered by its design, which provides too

much unused information and spreads important data over too many printouts.

If PEMS is to be retained it must have:  1) complete, current, and accurate data
                                                                     /
input from all Regions; 2) computer programs which will serve as significant

Regional as well as Headquarters tools; and, 3)  close coordination and clear under-

standing between the Regional pesticides programs and PED on how PEMS is to be

utilized.

    PED currently has a contractor revising PEMS. This effort is focused on both

cost reduction and systems improvement.  Of course the most important first

step is to create a simple process that will support basic Regional information

needs without unnecessary data base maintenance.

    Every Region stated that the PEMS Violative History Report was "all input and

no output."' Even Regions'that are conscientious about entering data to the system

utilize their hard copy files to determine a company's violative history.  This is

because:

     1)  Data is not always  accurately coded into the system and sometimes is
        garbled by the computer program.

     2)  It takes much longer to request and receive a print-out in the Region  than
        to go to the hard-copy files and manually obtain the violative history.

     3)  There are many gaps in the data base because some Regions are
        unable or unwilling to input required information on a timely basis.

     4)  Computer programs for data interpretation are not currently
        available to the Regions. Thus much of  the data is-not utilized.

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                                -13-


   The Review Team agrees with the necessity of continuing ADP support for

the pesticide enforcement effort.  This ADP support must, however, be based

on legitimate Headquarters oversight and Regional management needs.  There

is no reason for it to include all data associated with the program.

   Recommendation 6;  The current redesign of PEMS should focus on
developing a streamlined system that will be of practical use to all pesticides
enforcement managers. For example, the violative history report could be
simplified to contain only the following useful information: Establishment
registration number,  product number, ID number and date sampled, violation,
action  taken, and date of permanent abeyance.

   Recommendation 7; Information in PEMS that is not useful to the Regional
pesticides program should be deleted. The Scientific Support Branch must
assure that the modifications come from the suggestions of pesticide program
managers, and not just ADP  specialists.

   Recommendation 8;  The  Scientific Support Branch must develop computer
programs for accessing and evaluating the  data that will be in the streamlined
PEMS.

   Recommendation 9; Once PEMS is revised,  FED should develop a user's
manual that discusses the services and information PEMS can provide"!  This
handbook should go beyond a technical description of how  to enter data into
the system, which is the purpose of the PEMS Regional Operations Guide and
the PEMS Data Collection Manual.  It should explain for the benefit of program
personnel how PEMS can be utilized and what types of analyses can be performed.

   Inspection Workload; Table 1 shows a wide variation among the Regions in

the percentage of establishments inspected, and the number of products picked up

at each establishment.  In FY 75, 40% of all producer establishments in the Nation

were inspected (2274 of 5590 total).  The FY  76 Regional Guidance directed that

establishment inspection activities are to be deemphasized. *  The commitment by

the Regions for FY 76 is to inspect only 1713 establishments (31% of the total).
* The FY 76 Regional Guidance instructions for establishment inspection in-
  clude the statement ".. .the number of producer establishment inspections
  may be reduced with concurrent reduction in the number of samples taken. "
  (P. 15) This reduction of effort was recommended because of improvements
  in the  sampling system and greater emphasis on misuse enforcement.

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                                      -14-
                               TABLE I

                      Regional Producer Surveillance


REGION
I
II
' Ill
IV
V -
VI
VII
VIII
IX
X
TOTAL

No. of
Inspectors
3
8*
4
8
7
5
4
3
5**
3***
50
No. of

producing No. Estab.
e stabs.
185
513
395
1202
983
590
546
145
762
269
5590
inspected
116
236
213
497
357
245
241
89
227
53
2274
% of all
estab.
inspected
in FY 75
62
46
53
41
36
- 41
44
61
29
19
40%
No. of
products
reviewed
184
802
765
1136
1568
942
489
279
756
202
7123
Average
No. of
products
reviewed
per estab.
1.6
3.4
3.6
2.3
4.4
3.8
2.0
3.1-
3.3
3.8
- 3.1
 *  Does not include 2 import inspectors and 3 clerical.
 **  One additional inspector does case preparation full time.
*** The inspectors have extensive State technical
    assistance responsibilities.

SOURCE:  FY 75 FPRS data and ERSS information

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                               -15-


    However,  in the first half of FY 76,  establishment inspections were 38%

greater than planned, 1145  actual vs. 831 commitment.  (In the first half of FY 75

the Regions exceeded their commitment by only 13%). Apparently most Regions

are continuing their efforts at the same level, in spite of the guidance.


    Recommendation 10; Those Regions that have not as yet done so should re-
duce tne man-years applied to establishment inspections and focus on higher
priority needs.


   .In no Region did we observe a sufficient coordination of inspection activities

with States.  A 1974 GAO*  recommendation that EPA make better use of State

resources apparently has had little impact.  Where adequate State pesticide

enforcement programs  exist,  the Regional Offices should prepare a unified,

non-overlapping sampling strategy.  The activities to avoid needless duplication

should be specified in formal enforcement agreements.


    Recommendation 11;  Regional Offices should base their strategies on the
States1 capabilities. As a first step, copies of the Regional Guidance, Regional
commitments, and monthly or quarterly workplans and summaries,  as appro-
priate,  should be sent to the States.


    Chemical Analysis- The four Product Analysis Labs '(PAL) appear to be

serving the program well.  Every Region indicated PAL efficiency and reliability.

Although not organizationally "clean, " having four labs serve 10 regions  is

currently working satisfactorily.  In some  cases,  the PAL's and manufacturers

use different testing methods, which has caused some difficulties. These pre-

liminary conflicts will be reduced as standard methods are defined as part of
^General Accounting Office, Pesticides; Actions Needed to Protect the Con-
 sumer from Defective Products.  May 1974.  p. 40-44.                 ~

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                               -16-


the reregistration process.  Also, a manual of.chemical methods is now being

jointly prepared by TSD and the Association of Official Analytical Chemists.

However, to date there has not been a successful challenge to PAL evidence in

hearings.

    All four PAL's report to a Regional Surveillance and Analysis Division

Director.  Agreement on "quotas" for sampling must come from the PAL Director

and the various Regions served.   The Regional sampling program currently

picks up about 5000 samples each year.  Supposedly this is the laboratory testing

capacity.  However,  it is obvious from Table 2 that lab output varies considerably.

The high disparity in the number of samples analyzed per man year by each PAL

should be reviewed.

    Table 3 shows that the "quotas" match up reasonably well with the relative

number of registered products in each Region, although Region IV is considerably

short of its relative share. Table 3 also shows that those Regions served by


                             TABLE 2

           Product Analysis Laboratory Workload for FY 76
PAL
New York
Bay St. Louis
Denver
San Francisco
TOTAL
Man-ye.ars
10
8 •
4
6
28
Total Samples*
1775
1152
1000
750
4677
Sa-mples per MY
177.5
144
250
125

# The number of samples the PAL's committed to do.  Actual number of
   tests performed may vary.

SOURCE:  Regional interviews

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                                -17-


the New York or.Denver PAL's have a larger relative share of tests run than

those Regions served by the Bay St.  Louis or San Franciso PAL's.

    Recommendation 12:  PED, in consultation with the Technical Services.
Division,  the PAL Directors, and the Regional Pesticide Branch Chiefs, should
develop guidance for the PAL's oh quotas, priorities, residuals analysis,  Head-
quarters .support needs, manpower requirements,  and related issues.

    Scientific Support- Once a labeling violation, chemical discrepancy or  efficacy

problem has been identified during the inspection or subsequent product testing,

the Regional Pesticide Branch is responsible for taking appropriate enforcement

action.  In many cases, before any prosecutorial decisions are made, the  Branch

requires scientific opinion about the seriousness of-the violation. Through what

is known as the ID review process the  Branch sends the laboratory report  and

other pertinent data to Headquarters for review. Ideally,  the Branches should

have the scientific expertise to make their own determinations without having to

go through Headquarters. Such expertise would also enable the Branches to

assume more registration 'responsibilities and other technical duties. However,

as mentioned earlier,  resource constraints preclude the acquisition of such

expertise  at the present time.

    Currently,  the ID'S are sent by the Branch to PED which transmits the

package to the Registration Division for  review.  PED is creating a new  scientific

support section to do  the ID review without routinely having to go through the

Registration Division.  This change  should reduce the delays in the ID review

process noted by the Regions. -
                                                                     •
    Recommendation 13. Until the full development of the Scientific Support
Branch capabilities, the Registration Division should follow more closely the
progress of the ID through the review process to reduce delay.  A simplification
of the Division's current ID logging system would be extremely beneficial.  On
the fifteenth working day that the ID  is in the Division the ID coordinator should
contact the Region by phone and explain what is holding up the review and how
much longer it is expected to take.

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                               -18-


                             TABLE 3

              Regional Product Analysis Quotas for FY 76
REGION
I
II
III
IV
V
VI
VII
VIII
IX
X
TOTAL
Sample
. "Quota"*
250
625
300
600
1025
552
500
250
400
175
4677
%of
Total % of
Quota Products
5%
13%
6%
13%
22%
12%
11%
5%
9%
4%
2%
12%
7%
24%
17%
9%
10%
2%
13%
•4%
%of
Producers
3%
9%
7%
21%
18%
10%
10%
3%
14%
5%
PAL
Responsible
NY
NY
NY
BSL
Den-250,
NY -600,
SF-175
BSL
DEN
DEN
SF
SF
* The negotiated number of samples each Region is to send to its PAL.
  Actual number sent may vary. .

SOURCE: Regional interviews and ERSS data.
   A few Regions mentioned problems in completing enforcement actions

because of inconsistent procedures by OPP.  The person who conducts a

scientific review should sign the report and testify at any hearing or trial.

Apparently supervisors of the  scientists now  sign-off on the findings,  and

they are  frequently not prepared or qualified  to appear in support of the

conclusions in subsequent hearings on trials.

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                               -19-


    Recommendation 14;  OPP should develop procedures with PED to ensure
that whenever feasible the individual who reviews a product suspected of
violating FIFRA is the same one who participates in subsequent enforcement
procedures.  However, to the extent possible Regions should be the primary
source of expert witnesses for enforcement actions.

    Some friction has occured between at least one Region and the Chemical and

Biological Investigation Branch (CBIB) laboratories.  There is no mutually

satisfactory standard operating procedure for resolving conflicts between EPA

and a registrant's test data.  Consequently, the Region was frustrated in attempt-

ing to prosecute a registrant for a product that EPA labs found ineffective but

that the registrant's own tests showed  met the performance criteria.  CBIB

contends that its evidence was conclusive  enough to stand up in court.  The

Region did not agree.  Although this case  was eventually settled, the need exists

for specific procedures to prevent future misunderstandings.

    Recommendation  15; Representatives from the Technical Services Division
of OPP,  the. Pesticides Enforcement Division, the Office of General Counsel,
and the Regions should establish formal procedures for dealing with conflicting
test results. A process for resolving any future Regional/CBIB disagreements
or problems should also be prepared.

    C. Experimental Use Permits

    Section 5 of FIFRA provides for the issuance of experimental use permits

to prospective registrants for the purpose of gathering or developing necessary

data.  Regional personnel are responsible for monitoring the permits to ensure

that all conditions are met.  Currently all permits  submitted pursuant to §5(f)

are approved in OPP, although the  responsibility may be delegated to the  States.

The development and approval of State §5f plans must be a Regional responsibility

as well as the monitoring of the subsequent permit  program.  The Act required

publication of §5f regulations by October 1973.  They are expected in the summer

of 1976.

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                                -20-


    Recommendation 16;  When States submit plans for State issuance of experi-
mental use permits, the Regional Offices should have the lead responsibility for
review and approval.  Minimum acceptable standards for the State plans should
be clearly set forth in the Section 5 guidelines.

    D. Registration for  Special Local Needs

    Section 24(c) of FIFRA allows authorized States to register pesticide products

for special local needs.  This provision enables  States to secure a needed product

when no nationally registered product is available.  The authority to approve §24c

plans has not been delegated by the Administrator.

    Recommendation 17;  Regional Administrators should be delegated the authority
to approve State special  local use registration plans.

   Recommendation 18; During the ninety day period when EPA can reject a State
registration, both the Regional Office and the Registration Division should evaluate
the proposed registration.  The Regional Office should be responsible for assessing
the local problem and'economic impact of denial, while the Registration Division
should evaluate safely and effectiveness. This latter responsibility should be
delegated to any Region with a qualified  scientific support staff.

    E. Emergency Exemptions

    Section 18 of FIFRA allows the use of no'nregistered products under an emer-

gency exemption.-  Currently, §18 exemption requests are  made by the head of

a Federal Agency, a State Governor, or other official designee and go directly

to the Administrator.  It is  important that the Administrator make the final

decision because of the controversial nature and/or national implications of

granting an exemption.  However, the Region should be consulted for its own

assessment as soon as the request is received.   In the past State/Regional/

Headquarters coordination of exemption requests has not always been acceptable.

    Recommendation 19;  In  any future §18 exemption request, the Regional Office
must have major responsibility in assessing the problem and finding solutions.
They must receive a copy of the request as  soon as it arrives in Headquarters.
Final action on the exemption should be based on the  Regional Office recommen-
dation with Registration Division concurrence.  Copies of all State/Headquarters
correspondence  relating to the request should be sent to'the  Regional Office.

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                                -21-


    Recommendation 20; No  §18 exemptions, under any circumstanaces,
should be granted without Regional Office participation.

    Recommendation 21: Exemption requests should not be renewed by the
Administrator without a review to determine if the product should be registered
for the use in question.  The repeated exemption is, in effect, a de facto regis-
tration.  Either the use should be registered formally or it should be disallowed
except for extreme emergencies.

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                                    -22-





                        III. USE CONTROL



    EPA's use control objective is to ensure that pesticides a-re handled in  "



accordance with label directions. Activities undertaken in support of this ob-



jective include applicator training and certification, accident investigations



and use surveillance.  These activities are discussed in this section.



    A. Certification of Applicators



    FIFRA gives EPA the authority to classify especially dangerous pesticides



"for restricted use. "  Only an applicator who has been certified as competent



to handle them may do so.  Each State is responsible for the certification of its



applicators.  The Pesticide Branches' highest priority activity for the past two



years has been to assist States in developing acceptable certification programs.



Progress has been  slow for a variety of reasons, but with the extension of the
                                                               f


implementation deadline from October 1976 to October 1977, enough time remains



to finish the job in every Region.



    The current pesticides strategy indicates that the Regions should provide



final review and approval of State plans.  However, this authority has not been
                                          *


been delegated formally from the Assistant Administrator for Water and Hazard-



ous Materials to the Regional Administrators.  A'draft change order (1255.3



change 2) providing for the transfer of this  authority was once prepared but



never issued. Because the Regions have had the lead responsibility and have



worked long, hard and closely with their States, and because they are obligated



to ensure that the plan is properly implemented, the Regional Administrator



should be delegated the authority for final plan approval.  OPP concurrence
                            /


should be obtained, although even the concurrence requirement could be waived



in the case of capable Regions.

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                                     -23-

    Recommendatipn 22;  Draft change order 1255.3 change 2, delegating cer-
tification plan final approval to the Regional Administrator,  should be completed
and issued by July 1, 1976.

    Operation Division Support:  The Operations Division (OD) in OPP established

the basic requirements for an acceptable State certification plan. .The Division

now performs a vital support function, in assisting the Regions with the certi-

fication problems that arise with.certain States. While OD must be ready .

to provide  timely help when requested,  it must  not initiate direct State contact

without first contacting the Region.  Such unilateral action can cause embar-

rassment to or difficulties for the Pesticide Branch.

    Recommendation 23:  The Operations Division, ,or any other Headquarters
pesticide office,  should not deal directly with a State on substantive issues
without prior Regional consultation.

    Recommendation 24;  The Operations Division should provide comments on
any draft State plan within ten working days. Although this has been a standing
promise in the past, the deadline has rarely been achieved.

    Funding Control.  Federal funds are available to support State management

of the certification program.  EPA is administering grants totalling over $5

millon per year for this purpose. Another $5 million of EPA funds have been

transferred to USDA/Cooperative Extension Service for applicator training.

Criteria for monitoring of these funds must still be established.  The issue of

who is accountable for funds channeled  through  CES has yet to be resolved.

    Recommendation 25;  The Operations Division and the Office of Program
Development and Evaluation  (in OPP), after consultation with the Regions,
should specify who is accountable for each category of expenditure and what
means should be taken to ensure  that the certification and training objectives
attached to the grants are accomplished.

    B.  Accident Investigations

    Accident investigations are conducted by Regional personnel to provide OPP

with necessary substantiation of the magnitude and characteristics of pesticide

problems and to gather information for product labelling and registration decisions.

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                              -24-



Unfortunately,  the existing system (PERS: Pesticide ISpisode R_eview System)


does not serve either purpose.  Almost every Region indicated that accident


investigation was its least productive activity.  Although one work year of


effort was ostensibly devoted to accident investigation in each Region,  few


were able to use-it productively.  Several Regions used  the accident investi-


gator as an additional consumer safety officer to make inspections of producer


establishments.


   • Three fundamental problems with PERS were  reported.  First, the coverage


of the system is spotty.  Regional Offices receive accident reports from only


a very few sources.  Accuracy is often questionable, and, therefore,  inter-


pretation or extrapolation of the data is likely to result in misleading or mean-


ingless conclusions.  Second,  the reporting forms (PERF: P_esticide Episode


Reporting F_prm) were designed to minimize possible enforcement uses.  The


intention was to keep accident investigation a "blind".data gathering system to


reduce  the concern that reporting accidents would lead to enforcement actions.
        *                                                                      •

The result has been the exclusion of substantial amounts of vital information,


thereby reducing the utility of the system.  Third, the data entered into the


system has rarely been used,  probably because of the previous reasons. There-


fore, submitting quality data has been a low priority activity in the Regions.


    The output of PERS is minimal compared with the energy and resources that


are required to run  the system. A fundamental restructuring of PERS is needed.


This remodeling should be done in the context of related data gathering activities.


After all, accident investigation is only one way of collecting hazard information.


Epidemiological studies, formal hospital or household surveys and use obser-


vations may be more effective and efficient methods for obtaining the  same


information,

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                                      -25-


     PERS should operate in conjunction with other pesticide monitoring and

 assessment programs.  The Technical Services Division is now developing a

 system to provide a structure for the collection and evaluation of pesticides

 hazard data.  PERS should be a complimentary element of-this  system.

     Recommendation 26;  Responsibility for the management of  PERS should be
 transferred immediately from the Operations Division to the Technical Services
 Division to insure its integration with the hazard evaluation system.

     Recommendation 27;  The utility of PERS vis-a-vis other hazard information
 collection alternatives should be assessed at the earliest possible time and
 appropriate revisions intitiated.

     C.  Use Surveillance                      "

     A program of use surveillance is necessary to ensure that all applicators

 follow label directions and that only certified applicators use restricted products.

 Section 15B of the PED inspectors' manual explicitly describes  the purposes of

 inspections.  The range of goals extends from enforcing compliance with use

 directions to determining whether product label changes are needed.  There are

 two parts to use  surveillance activity:  use observation and misuse  investigation.

 Use observation  consists of .an EPA inspector being present during  the application

 of a pesticide to  determine if label directions are properly followed.  Applicator

' consent is required,  since EPA has no authority to enter private property unless

 a violation is suspected.  Misuse inspections are investigations of specific alleged

 violations of the  law.  They are initiated when a possible breach of  the law comes

 to the attention of the Regional Office.  Misuse investigations are made to deter-
          -i       "              .
 mine if an enforcement action is warranted.

     The FY 76 Headquarters Guidance to the Regions indicated that  forty percent

 of pesticides enforcement resources should be devoted to use surveillance

 activities.  While the Regions ail agreed that increased emphasis on use

 enforcement was desirable,  there was strong sentiment that Headquarters was

-------
                                     -26-


trying to move too fast.  The certified applicator provisions of the law do

not come into effect until October 1977, so no enforcement in this area is

yet required.  More importantly,  the Agency has just begun to deal with  the

complexities of pesticide use.  Until the "rules of the game" have been codified

in the Pesticides Enforcement  Policy  Statements (PEPS) series, Regional en-

forcement efforts will be fragmented and inconsistent.

    The FY  77 Guidance  recommends a reduction in use surveillance activity to

thirty per cent of Regional pesticides enforcement resources. Increased

emphasis is to be placed on establishing cooperative enforcement agreements

with the States.  The Review Team believes that strong State participation is

essential for a successful use control  program since EPA's resources are too

limited to assure adequate local coverage and  since State personnel often have

better access to use information.  Region X has taken the initiative in develop-

ing a mutually beneficial division of labor with its States.  The Region will

have responsibility for a strong supply control program, while the States will
                                    •
emphasize use enforcement. If a problem is too big or complex for one  party to

handle, the  other will assist.  Region  IV  (with  North Carolina) and Region IX

(with California)  also have developed programs.  These approaches are illus-

trative of the direction in which all Regions must head,  namely,  getting the

States  involved.

    Recommendation 28; Before FY 77,  a national meeting of all Pesticide
Branch Chiefs  should be held to discuss use enforcement.  Representatives
from the Denver  NEIC, OPP, and PED should  attend.  Within one month of the
meeting, PED  should have'prepared a  document that summarizes the discussions
held, and describes in detail appropriate strategies and activities for use
surveillance.

    Recommendation 29; In the time remaining before the applicator certification
requirements go  into effect pesticide inspectors should spend as much time as
possible oh  use observation and acquainting applicators with the use requirements.
Familiarizing potentially affected applicators with the Pesticide Enforcement
Policy Statements should be a high priority for both Regional and Headquarters
personnel in FY 77.

-------
                               -27-


    The law empowers EPA to respond to use by issuing either a non-punitive

§9c warning or a §14(a)(2) warning which is the first step towards a civil action.

In egregious cases, criminal proceedings  can be instituted.  All misuse  enforce-

ment cases currently have to be cleared by the JPesticides Misuse Review Com-

mittee (PMRC), consisting of members from FED, the Registration Division,

and the Office of General Counsel.

    Misuse review has been slow and cumbersome, partially because FED has

provided no standard format for submission.  Actions have been referred by

the Regions in stages of preparation ranging from brief summaries to entire

case files without any recommended action.  Before the PMRC can conduct a

review, it must summarize the file. Often the review that takes place after the

paperwork is done is purely routine. In many cases, the  PMRC review adds nothing

of substance to the enforcement process.

    Recommendation  30;  The Regions  should have the primary responsibility for
handling use enforcement cases. FED should waive concurrence on §9c and 14(a)(2)
warnings for most Regions now, and for all Regions as soon as they gain sufficient
experience.  During this period of use enforcement policy development, the
Regions should provide PED with a simple one page "fill-in-the-blanks" summary
of use warnings sent out.

    Recommendation  31;  Regions should submit misuse cases in a standard for-
mat that includes a proposed action. The standardized format should eliminate the
need to make summaries in Headquarters.  The PMRC should review sumitted
case summaries and  make a  recommendation within ten working days.  The Regional
offices must be given copies of any additional information that is provided on the
case by the Registration Division.

    Rec ommendation 32;  The Scientific Support Branch of PED should revise the
PMRC Manual to reflect recent  policy  and organizational changes and to prescribe
formating and procedural changes that will eliminate process delays.

    Laboratory Support -  The Regions require adequate laboratory support to dis-

charge use control responsibilities effectively. .The laboratories must provide

analysis of residues, environmental monitoring of specific incidents,  and scientific

evaluation of the impact of suspect pesticide uses.  The Regions do not receive

-------
                                  -28-


this necessary assistance now.  For example,  no clear policy indicates where

Regions are to send use related samples for analysis (to a PAL,  the NEIC,

the Regional S&A laboratory,  to TSD labs, or to a contractor).

    Recommendation 33: The Directors of the Technical Services Division, the
Pesticides Enforcement Division and the Denver NEIC should establish policy
for the evaluation of residue samples.   Analytic needs and priorities should be
clarified, catelogued,  and.then communicated to the Pesticide Branches.

    Most Regional Pesticide Branches  are unaware of the technical and analytical

support services offered by the National Enforcement Investigation Center

(NEIC) at Denver.  The NEIC, in turn, seems somewhat unaware of some of

the problems involved  in pesticide use enforcement.  One possible cause of this

problem  is that the NEIC responds first to requests from the Regional Enforce-

ment Division Directors, while the lead responsibility for pesticides enforcement

is generally in the Air and Hazardous Materials Division.

    In FY 76 the NEIC  has 14 man-years for pesticide programs.  To date, most

effort has focused on support to the Office of General Counsel for the Chlordane'/

Heptachlor cancellation and to the Regions on NPDES permits associated with

water discharges by pesticides manufacturers.

    Recommendation 34; The Office of Enforcement,  in consultation with  PED,
NEIu, and the Regions, should develop clear guidance on the NEIC's pesticides
reponsibilities and capabilities. This  should include an understanding of priorities
among the appropriate decision-makers in FED,  the NEIC,  and in each Region.

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                                -29-


                    IV.  HAZARD EVALUATION

    Although the identification and assessment of the possible dangers inherent

in pesticide use is one of EPA's most important responsibilities, hazard eval-

uation has not been emphasized as much as supply control and use control.

Recently, however, OPP has placed greater priority on the development of a

H_azard Evaluation "System  (HES).  The objective of HES is to provide a mecha-

nism for structuring, interrelating,  and evaluating data about the hazards of

pesticides use in order to produce information useful for  policy development

    Regional participation in the design and operation of the HES is imperative

since the Regions should be a  continuous source of information about pesticide

products and uses.  Accident investigation is the only Regional activity which

currently provides  a formal hazard assessment input. Other. Regional activities,

e.g. enforcement and applicator training,  generate useful information about

pesticide problems. Also,  the Regions may acquire an important role in

monitoring pesticides in the environment,  as is recommended in the National

Pesticide Monitoring Plan.  The Regions need a clear statement of their evaluation

responsibilities. The  Branch Chiefs from Regions V and IX have been selected

to coordinate and integrate Regional inputs to HES. However, major features

of the plan should be sent directly to  all Regions for review.  Regions have the

responsibility to respond promptly and carefully to all requests for comment's.

    Recommendation 35: The  DAA for Pesticides  should complete the Hazard
Evaluation planning effort by November 1976.

    Re.commendation 36; The  Pesticides Enforcement Division should be involved
in developing the HES.  Pesticides inspectors are an important  source of pesticide
field information.  Their experience  and knowledge about product uses and pro-
blems should be a major input into the HES.

-------
                                 -30-


    Recommendation 37; The Regions should be involved in the design, im-
plementation, and operation of HES.

    Recommendation 38; As  HES requirements for ambient monitoring become
defined,  appropriate resources and directions should be provided by OPP to en-
sure close Headquarters/Regional/State coordination of effort.

    The Pesticide Branches could conduct their enforcement and other regulatory

activities more efficiently if  they had the suspect chemical, suspect product,

and suspect use lists prepared by the Technical Services Division and Criteria

and Evaluation Division. The Branches report that nothing from these lists

has ever been communicated  to them.  It is extremely important to distribute

all available information.  Furthermore, intelligence and advice from the

Pesticide Branches themselves should be inputs to the development of the listings
    Recommendation 39; The Operations Division should send immediately
all available suspect chemical, suspect product or suspect use information
to the Regions.

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                                -31-



                         V.  Manpower Resources



    One of the major thrusts of this report is that Regional responsibilities


for pesticide programs should be expanded.   The Review Team believes that


a greater decentralization of the program is desirable once the currently


pressing legal deadlines have been satisfied.  Only one out of five pesticides


positions is now in the Regions (see Tables 4 & 5). On the other hand, air


programs have nearly one of every two people in the Regions,  and water pro-
                •

grams over four out of five.  This concentration of position at Headquarters


is not in the best interests of the program.  We recommend that the Agency

                                                                •
begin now to manage the manpower resources devoted to pesticides in such


a way as to make the implementation of a decentralization strategy possible.


In the interim any reductions mandated in overall pesticides resources should


be absorbed by Headquarters elements, rather than the Regions.


    Some workload problems were noted during our Regional visits, although


in several  cases pesticide resources were not devoted to pesticide  activities.


A few Regions appear overworked, while others seem to be relatively over-


staffed.  The Review Team has compared in each Region the allocated personnel


and the expected relative workload.


    The assumption was made that the manpower for each pesticide activity


should be proportional to the level suggested in the FY77 draft Regional


Guidance.  This model does  not determine optimal position allocation (for


example, the number of inspectors necessary to cover 1000 establishments).


It only shows the preferred distribution of currently available manpower re-


sources.  Accordingly, the following weighting factors were used:

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                                    .  -32-


    Technical Assistance  (81 positions)

    Two positions allocated to each Region (20 positions) the 61 remaining

positions allocated as follows:

      66. 67% for applicator training and certification (40. 66 positions)"

      22.22% for Section 24(c) and Section 5(f) responsibilities (13.55 positions)

      11.11% for integrated pest management and accident
             investigation (6.77 positions)

    Enforcement (111 positions - 2 import positions in Region II were not included)

    Three positions allocated to each Region (30 positions) the 81  remaining

positions allocated as follows:

      33.33% for State cooperative  enforcement (27 positions)

      33.33% for producer surveillance (27 positions)

      33.33% for use observations and enforcement (27 positions)

    Criteria were then selected for apportioning available positions in each

category among the ten Regions.  The following parameters were used in deter-

mining the workload of each Region and the number of positions to be assigned.

                      Technical Assistance

   Applicator Training and Certification (40.66 total positions)

      --60% (24.4 positions) allocated on the basis of the number  of

        States in the Region (e.g. if a Region has 10% of all U. S.  States

        it would get  10% of these  24.4 positions: 10% x 24.4 =  2. 44 positions).

      --20% (8.13 positions) allocated on the basis of the percentage of all

        U. S. farmers and farm managers in the Region (e.g., if  a Region has

        14% of U. S.  farmers and managers it would get 14% of these  8.13

        positions: 14% x 8.13 = 1.14  positions).

      --20% (8.13 positions) allocated on the basis of the percentage of U. S.

        population located in the  Region.

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                                -33-
24(c) and 5(f) (13.55 total positions)
    --100% (13.55 positions) allocated on the basis of the percentage
      of all experimental use permits issued in the Region in 1975.
                                                         •
      (This may not be a completely accurate projection of future 24(c)
      and 5(f) workload).
Integrated pest management and accident investigation (6. 78 total positions)
    --33.33% (2.26 positions) allocated on the basis of the percentage
      of U.S. farmers located in the Region.
    --33.33% (2.26 positions) allocated on the basis of the percentage
      of the U.'S. population located in the Region.
    --33. 33% (2. 26 positions) allocated on the basis of the percentage
      of involuntary pesticide poisoning hospital admissions in the Region.
                          Enforcement
State Cooperative Enforcement (27 total positions)
    -"100% (27 positions) allocated on the basis of the percentage
      of States located in the Region.
Producer Surveillance (27  total positions)
    —66.67% (18 positions) allocated on the basis of the percentage
      of all U.S.  pesticide producers located in the Region.
    --33. 33% (9 positions) allocated on the basis of the  percentage
      of all pesticide products made in the Region.
Use Observations and Enforcement (27 total positions)
    --16.67% (4.5 positions)  allocated on the basis  of the percentage
      of all U.S.  farms located in the Regions.
    --16.67% (4.5 positions)  allocated on the basis  of the percentage
      of U. S.  farmers and farm managers located  in the Region.

-------
                                     -34-
       --33.33% (9 positions) allocated on the basis of the percentage



         of the U.S. population located in the Region.



       --33. 33%. (9 positions) allocated on the basis of the percentage



         of all involuntary pesticide poisoning hospital admissions



         located in the Region.



    The results are displayed in Tables 6, 7, and 8 (Table 9 presents the



Regional percentages used in the computation). More staff appear needed in



Regions III and IV. The greatest single reduction is suggested for Region II,



where, allowing for 2 customs and 10 Pesticide Analysis Laboratory personnel,



the analysis indicated a loss of 6 positions.



    Admittedly, any allocation formula is open to objections.  However, the



Review Team believes that this methodology represents a reasonable first step.



More importantly, it is generally in accord with the impressions developed by



the Team in the course of its Regional visits.  We believe that any adjustments



in Regional resources  should be guided by the distribution ratios presented above.

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                                          -35-


                                  TABLE 4
                   Headquarters/Regional Personnel Allocations
                            Air, Water,  Pesticides
          AIR                    WATER                 PESTICIDES
          Reg.    HQ    TOTAL Reg.      HQ     TOTAL "Reg:     HQ    . TOTAL

          293     510             1584     435              81       624
         (36.5%)  (63.5%)  803     (78.5%) (21.5%)   2019    (11.5%)  (88.5%)   705

          309    153              737     100              113       34
         (66.9%)  (33.1%)  462     (88.1%) (11.9%)   837    (76.9%)  (23.1%)   147
   »

TOTALS  602    663              2321     535              194       658
         (47.6%)  (52.4%)  1265     (81.3%) (18.7%)  2856    (22.8%)  (77.2%)   852

xOTAL
 MANPOWER
          4937


              AIR           1265    25.4%

              WATER  '  '   2856    57.4%

              PESTICIDES    852    17.2%

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                                  -36-


                              TABLE 5

                   Total Pesticides Program Personnel

Regions

   Abatement and Control      .-       81

   Enforcement   •                   113

   Pesticide Analysis Labs      -       28
              TOTAL                T2T

Headquarters

  . Pesticides  Enforcement  Div -       34

  . Office of Pesticides Programs  - current ceiling
    (by Program Sub-Element)

   Accident Investigation              10

   Technical Support                   42

   Substitute Chemicals                35

   Registration                       224

   Criteria & Standards                164

   Epidemic logical Studies              13

   Residue Profiles                    37

   Technical Information               63

   Program Management               33

   EIS Preparation                    	3

       TOTAL                        624

The current OPP distribution by Division  is approximately:

   Immediate Office of the DAA          52

   Operations Division                   41

   Technical Services Division          186

   Registration Division                226

   Criteria & Evaluation Div.           140

       TOTAL                         645

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                                        -37-
~ egions

&\) positions
  evenly

_f 61 remaining
  positions -
   •
        60% states
66.67%
~ert.   20% farmers
  >p.
prog.    20% pop.

  1.22%
-xf)and 24(c)

  >M    33.33% farmers

ACC    33.33% pop.
  1.11%
        33.33% Hosp.
                   TABLE 6
                                •
Model for Regional Pesticide Manpower Allocations*

           Abatement and Control**

                81 Positions**

        I     II    III     IV     V     VI    VII   VIII
IX
                Ads.
     TOTAL

Present
  [location
     DIFFERENCE***
X
2
2.71
.12
.42
.81
.03
.12
.05
6.26
7
-.74
2
1.81
.32
1.10
.68
.09
.30
.06
6.36
6
+.36
2
2.71
.46
.89
1.22
.13
.25
.23
7.89
6
+1.89
2
3.61
1.33
1.23
2.71
.37
.34
.51
12. 10
8
+4.10
2
2.71
2.04
1.72
2.03
.57
.48
.38
11.93
10
+1.93
2
2.24
.91
.78
1.76
.25
.22
.38
8.54
10
-1.46
2
1.81
1.62
.44
1.36
.45
-.12
.13
7.93
7
+.93
2
2.71
.72
.21
1.22
.20
.06
.08
7.20
10
-2.80
2
2.24
.30
1.11
.95
.08
.31
.36
7.35
9
-.1.65
2
1.81
.30
.24
.95
.08
.07
.09
5.54
8
-2.46
       See Table 5 for regional percentages used to compute man years.

       These numbers do not include Product Analysis Laboratory, or import
       inspectors (Region II)
       .12 man years lost due  to rounding

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                                     -38-


                                   TABLE 7

                                  Enforcement

                                 111 Positions*
Regions

30 positions
  evenly

Df 81 remaining
  positions -

33". 33% co-op
  enf. (States)

          66.67%
33.33%    producers
Indus.
3urv.     33.33%
           products

          .16.67%
           farms

           16.67%
J3.33%    farmers
ase
           33.33%
           pop.

           33.33%
           Hosp.
          Adms.

    TOTAL

Present
Allocation

.Difference
II     III    IV
VI    VII    VIII    IX     X
3
3
.59
.18
.05
.07
.47
.19
7.55
6
+1.55
3
2
1.66
1.08
.10
.18
1.22
.24
9.48
17
-7.52
3
3
1.28
.63
.28
.26
.98
.91
10.34
10
+.34
3
4
S..87
2.. 16
1.08
.74
^1. 36
2.01
18.22
17
+1.22
3
3
3.17
1.53
1.03
1.13
1.90
1.50
16.26
21
-4.74
3
2.5
1.89
.81
.68
.50
.86
1.50
11.74
9 •
+2.74
3
2.0'
1.76
.90
.72
.90
.49
.54
10.31
12
-1.69
3
3.0
.45
.18
.27
.40
.23
.30
7.83
5
+2.83
3
2.5
2.47
1.17
.15
.17
1.22
1.45
12.13
10
+2.13
3
3
.86
.36
.14
.17
.27
.35
7.15
4
+3.15
   See Table 8 for regional percentages used to compute man years.

   These numbers do not include Product Analysis Laboratory, or import
   inspectors (Region II)

-------
                                    -39-
                                  TABLE 8

                     Total Regional Position Differentials**
                  (Difference Row of Tables 6 & 7 Combined)
I
f .8
II
-6.2
HI IV V VI VII VIII - DC X
+2.2
+5.3
-2.8
+1.3
- .8
even
+ .5
+ .7
** .4 man years lost from rounding error
                                  TABLE 9

         Percentages Used To Model The Regional Personnel Distribution
Regions
States per Region
  (54 Total)

Farmers and
  Farm Managers

Population

Producers

Products

Farms

Exp. Use Permits

Involuntary Hosp.
  Admissions
I
11.1
1.5
5.2
3.3
•2.0
1.1
6.0
2.1
II III IV V VI VII VIII . DC X
7.4
3.9
13.5
9.2
12.0
2.2
5.0
2.7
11.1
5.7
10.9
7.1
7.0
6.3
9.0
10.2
14.8
16.4
15.1
21.5
24.0
23.9
20.0
22.4
11.1
25.1
21.1
17.6
17.0
22.9
15.0
16.7
•9.2
11.2
-9.6
10.5
9.0
15.1
13.0
16.7
7.4
19.9
5.4
9.8
10.0
15.9
10.0
6.0
11.1
8.9
2.6
2.5
2.0
6.1
9.0
3.3
9.2
3.7
13.6
13.7
13.0
3.3
7.0
16.1
7.4
3.7
3.0
4.8
4.0
3.2
7.0
3.9

-------